Evolocumab Versus LDL Apheresis in Patients With Hypercholesterolemia

Hypercholesterolemia Clinical Trial

Official title:

Comparative Pilot Study of the Effectiveness of Evolocumab Versus LDL Apheresis in Patients With Hypercholesterolemia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03429998
• Other study ID #: EVOLAFER01
• Status: Completed
• Phase: Phase 3
• First received: January 28, 2018
• Last updated: February 9, 2018
• Start date: April 1, 2017
• Est. completion date: January 28, 2018

Study information

• Verified date: February 2018
• Source: Hospital General Universitario Gregorio Marañon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

An open-label, prospective phase III study to compare the efficacy and safety of administering evolocumab versus treatment with LDLapheresis in patients with familial hypercholesterolemia and high cardiovascular risk.

Description:

STUDY DESIGN An open-label, prospective phase III study to compare the efficacy and safety of administering evolocumab versus treatment with LDLapheresis in patients with familial hypercholesterolemia and high cardiovascular risk.

STUDY POPULATION The chosen population is constituted by patients belonging to the LDL-apheresis program of the General University Hospital Gregorio Marañón with the diagnosis of familial hypercholesterolemia and a history of cardiovascular disease.

Number of patients expected to participate in the study according to the base of patients treated with LDL-apheresis: 10.

STUDY DESIGN:

Non-controlled intervention study to evaluate the different therapies in the treatment of hypercholesterolemia, in which each patient will be self-controlled. The variables will be analyzed during different phases

1. LDL-apheresis phase: Retrospectively during the previous year, pre- and postapheresis variables will be collected from the following lipid parameters: total cholesterol, LDL-cholesterol, HDL-cholesterol, triglycerides, atherogenicity index, Lipoprotein A, apo-A, apo- B; inflammatory parameters: PCR, ferritin, fibrinogen, leukocytes and polymorphonuclear and immunological parameters: immunoglobulins and complement.

2. Evolocumab phase: LDL-apheresis will be suspended for three months and Evolocumab administered: 140 mg / 15 days subcutaneously. The same parameters indicated in the previous section will be measured every two weeks.

3. Combined phase: During the following three months evolocumab will continue to be administered biweekly and the LDL-apheresis procedure will be spaced from biweekly to monthly, the same analytical parameters being measured again every two weeks.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: January 28, 2018
• Est. primary completion date: January 28, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• patients with age> 18 years

• hypercholesterolemia with LDL-cholesterol> 100 mg / dl in treatment with the maximum dose tolerated by statins and a history of severe cardiovascular disease

• patients who are included in the LDL-apheresis / biweekly program

Exclusion Criteria:

• contraindications to receive evolocumab according to technical data.

• hospital admission of any cause in the last three months prior to the inclusion of the study

• cardiovascular event in the three months prior to the inclusion of the study

• Inability to sign informed consent

• pregnant women and non-menopausal women who do not use at least one adequate contraceptive method

Related Conditions & MeSH terms

• Hypercholesterolemia

Intervention

Drug:
• evolocumab
evolocumab 140 mg/biweekly
• evolocumab and LDL apheresis
evolocumab 140 mg/biweekly LDL-apheresis monthly

Procedure:
• LDL apheresis
LDL apheresis biweekly

Locations

Country	Name	City	State
Spain	Hospital General Universitario Gregorio Marañon	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Hospital General Universitario Gregorio Marañon

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	decrease in LDL-cholesterol (mg/dl)	decrease in LDL-cholesterol levels in all three phases: LDL-apheresis, evolocumab and combined	9 months
Secondary	Decrease apo-B (mg/dl) levels	decrease in Apolipoprotein B levels in all three phases	9 months
Secondary	Decrease lipoprotein A (mg/dl) levels	decrease in lipoprotein A levels in all three phases	9 months
Secondary	Decrease in triglycerides (mg/dl) levels	Decrease in triglycerides levels in all three phases	9 months
Secondary	any adverse effects	any serious adverse effects	9 months
Secondary	Modification of C reactive protein	Effect of evolocumab and LDL-apheresis on C reactive protein levels (mg/l)	9 months
Secondary	Modification of immunoglobulin G levels (mg/dl)	Effect of of evolocumab and LDL-apheresis on immunoglobulin (mg/dl)	9 months
Secondary	Modification of immunoglobulin A levels (mg/dl)	Effect of evolocumab and LDLapheresis on immunoglobulin A (mg/dl)	9 months
Secondary	Modification of complement levels (mg/dl)	Effect of evolocumab and LDL apheresis on serum complement (mg/dl)	9 months
Secondary	Modification of serum fibrinogen (mg/dl)	Effect of evolocumab and LDL-apheresis on serum fibrinogen (mg/dl)	9 months